Classifications

• • G—PHYSICS
  • G01—MEASURING; TESTING
  • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
  • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
  • G01N35/00584—Control arrangements for automatic analysers
  • G01N35/00594—Quality control, including calibration or testing of components of the analyser
• • G—PHYSICS
  • G01—MEASURING; TESTING
  • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
  • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
  • G01N35/00584—Control arrangements for automatic analysers
• • G—PHYSICS
  • G01—MEASURING; TESTING
  • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
  • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
  • G01N35/00584—Control arrangements for automatic analysers
  • G01N35/0092—Scheduling
• • G—PHYSICS
  • G01—MEASURING; TESTING
  • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
  • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
  • G01N35/0099—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor comprising robots or similar manipulators
• • G—PHYSICS
  • G01—MEASURING; TESTING
  • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
  • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
  • G01N35/02—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor using a plurality of sample containers moved by a conveyor system past one or more treatment or analysis stations
  • G01N35/04—Details of the conveyor system
• • G—PHYSICS
  • G01—MEASURING; TESTING
  • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
  • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
  • G01N35/10—Devices for transferring samples or any liquids to, in, or from, the analysis apparatus, e.g. suction devices, injection devices
  • G01N35/1095—Devices for transferring samples or any liquids to, in, or from, the analysis apparatus, e.g. suction devices, injection devices for supplying the samples to flow-through analysers
  • G01N35/1097—Devices for transferring samples or any liquids to, in, or from, the analysis apparatus, e.g. suction devices, injection devices for supplying the samples to flow-through analysers characterised by the valves
• • G—PHYSICS
  • G01—MEASURING; TESTING
  • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
  • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
  • G01N2035/00465—Separating and mixing arrangements
  • G01N2035/00524—Mixing by agitating sample carrier
• • G—PHYSICS
  • G01—MEASURING; TESTING
  • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
  • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
  • G01N35/02—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor using a plurality of sample containers moved by a conveyor system past one or more treatment or analysis stations
  • G01N35/04—Details of the conveyor system
  • G01N2035/0401—Sample carriers, cuvettes or reaction vessels
  • G01N2035/0406—Individual bottles or tubes
• • G—PHYSICS
  • G01—MEASURING; TESTING
  • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
  • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
  • G01N35/00584—Control arrangements for automatic analysers
  • G01N35/00594—Quality control, including calibration or testing of components of the analyser
  • G01N35/00712—Automatic status testing, e.g. at start-up or periodic
• • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
  • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
  • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
  • Y10T436/00—Chemistry: analytical and immunological testing
  • Y10T436/10—Composition for standardization, calibration, simulation, stabilization, preparation or preservation; processes of use in preparation for chemical testing
• • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
  • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
  • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
  • Y10T436/00—Chemistry: analytical and immunological testing
  • Y10T436/11—Automated chemical analysis
  • Y10T436/113332—Automated chemical analysis with conveyance of sample along a test line in a container or rack
  • Y10T436/114165—Automated chemical analysis with conveyance of sample along a test line in a container or rack with step of insertion or removal from test line

Definitions

• the present invention relates to a method for preparing whole blood samples for carrying out hematology analysis (s) using automatic whole blood analyzer (s) as well as an automatic blood test device (s). preparation for its implementation.
• the purpose of the invention is, among other things, to define a protocol for the automated preparation of whole blood samples, which makes it possible to improve the reliability of the analyzes carried out on the basis of automatic analyzers, as well as the flexibility of implementing such analyzes at the same time. using such automatic analyzers.
• Blood tests on whole blood are carried out on blood tubes containing all the elements of the blood contrary to the analyzes carried out on plasma or blood serum, which are obtained after centrifugation or coagulation of the blood samples taken from the patients.
• These analyzes on whole blood require, to be correctly carried out, a sustained agitation of the blood tubes to be analyzed in order to mix well all the constituents of the blood such as the platelets and the red and white globules which one will count during analysis.
• This agitation phase is essential to ensure the quality of the analyzes and must be performed according to standardized criteria very shortly before the analysis.
• the blood tubes to be analyzed are identified by a barcode giving access to the patient information as well as the analyzes to be performed on the blood samples contained in the tubes.
• tubes are sorted into categories and placed on supports, commonly called “racks", adapted to receive a plurality of tubes. After pre-shaking, they can then be manually introduced individually into an automatic analyzer.
• the tubes can also be arranged in cassettes or "racks", specific to each analyzer and comprising about ten lined housings, in which the tubes are arranged and generally manually fixed by an operator, who then disposes said cassettes or "racks" in a load compartment of the analyzer.
• Said cassettes are then automatically taken care of by the analyzer which carries out the conveying, the stirring of the tubes, the analysis of the blood samples contained in each tube, and finally the storage of said cassettes once the set of blood tubes placed on these cassettes has been analyzed.
• the operator For each tube to be analyzed, the operator must take care to firmly push the blood tube into the cassette, turn it so as to make visible the barcode label used to identify it to the reader and not to contaminate with the blood.
• Automated supply chains of tubes to be analyzed are also known from a storage area to the point of analysis where they are supported by one or more analyzers as described in US 5232081.
• This is a conveyor chain of cassettes filled with tubes and arranged on a rail which transports the cassettes from one analyzer to another from a storage compartment, the placing of the cassettes on the conveying rail being performed automatically according to the rate of the analyzers.
• This type of automated supply chains for blood tube analyzers does not solve the flexibility problems of implementing the analyzes defined above, although they make it possible to improve their rate.
• the conveying of entire cassettes requires the construction of a large conveyor system to allow changes of direction of the cassettes on the chain in short radius curves, which makes the use of such cassette conveyor chains particularly impractical and difficult in the laboratories.
• EP-A-0344819 which describes a device essentially for storing and mixing blood tubes to be analyzed.
• the device provides only the agitation of the tubes and no further sample preparation step.
• Each tube is disposed on an individual support in a storage area, then, one by one, the tubes are successively moved by an excessively complex and bulky mechanism to the stirring device and an access area to an analyzer.
• this device suffers the same disadvantages as the cassette analysis devices. It is necessary for the operators to introduce one by one the tubes in their support in the storage compartment. In addition, its operation allows no flexibility in the order of preparation and analysis of the tubes.
• US 4927545 discloses an automatic blood serum processing device having a computer control and control unit driving a robotic 5-axis arm to manipulate test tubes. blood serum between different devices.
• this device has a very large footprint that makes it unusable in laboratories where a very large number of analyzes must be performed every day and where a large number of operators circulate and work.
• the device of US 4927545 does not allow to treat samples of whole blood to the extent that it does not allow an individualized and automatic preparation of the tubes.
• Control blood tubes should be kept in refrigerators when not in use, so that for each control the operators should stop the analyzer, then take a tube of appropriate control blood in a refrigerator, and check if this tube is appropriate for the control to be performed, whether the control blood has not expired and has not already undergone too many tests. Then, it is necessary to let the control blood tubes take up the temperature of the room then to carry out the control by practicing the analysis of the blood of control in accordance with the norms in force and finally, once the control finished, put the tubes in the refrigerator then resume the normal course of analysis.
• An object of the present invention is therefore to provide a method for preparing analyzes of whole blood samples for supplying an automatic analyzer with these samples by overcoming the drawbacks associated with the use of current automatic analyzers.
• the present invention aims in particular to provide a preparation method that makes the implementation of hematology analyzes more flexible, including facilitating the management of emergency analysis.
• An object of the invention is also to provide a method for preparing analyzes, in particular whole blood samples for solving the problems related to the quality control operations of the analyzers.
• Another object of the invention is to propose a process which makes it possible to improve the reliability of the analyzes carried out, in particular by ensuring perfect conditioning of the tubes containing the samples to be analyzed but also by autonomously managing the control and adjustment phases. of the analyzer.
• the invention also aims at providing a device dedicated to the preparation of analyzes of whole blood samples according to the method of the invention.
• the invention achieves its aims by a method for preparing analyzes of whole blood samples, said samples being stored in tubes comprising a means of identifying the sample and preferably being hermetically closed by a stopper, and characterized in that successively: a) a said tube is placed in a storage zone and identified by reading said identification means with a means of appropriate reading and recording of the information read in a control automaton in order to know the identity of the patient and the type of analysis to be performed on the blood sample contained in said tube, and b) the tube is taken and moved individually.
• step a) said tubes are placed and held vertically in supports comprising a plurality of individual housings of appropriate format for the reception of a tube and organized in a plurality of rows of contiguous housings, said supports being positioned in a said storage area capable of receiving a plurality of said supports and accessible by said robotic gripping and moving means.
• step c) At least one of the following additional preparation operations is preferably carried out:
• step c) also to heat up, preferably a heating, said sample.
• step e) the tubes are sorted and stored in different said supports using said robotic gripping and moving means according to the results of the analyzes performed on the samples. contained in said tubes, or depending on the place to optimize in the rack, or based on additional analyzes on said samples.
• the accuracy of automatic analyzers must be checked every day before analyzing unknown blood samples.
• the analysis of at least one sample of control blood is periodically prepared after preparation and analysis of a certain number of samples. samples of whole blood in a said analyzer, said control blood sample being taken, prepared and brought to the analyzer, then recovered and stored by said robotic gripping and moving means.
• the method of the invention comprises a protocol for automatically checking the validity of the analysis results performed by the automatic analyzer.
• a protocol for automatically checking the validity of the analysis results performed by the automatic analyzer For this purpose according to the invention: an average of each of the analyzed parameters is carried out on a series of unknown whole blood samples of a given number, and
• a control sample is prepared and the analysis of this same parameter is carried out on this control sample, and - if the measured value of the analyzed parameter on the control blood is within the nominal range of that parameter, the analysis of a new series of unknown whole blood samples is continued, and - if the value of the analyzed parameter on the control blood is located outside the nominal range of said parameter, a calibration of said analyzer is carried out before analysis of a new series of unknown whole blood samples.
• the invention also provides an automatic device useful for the preparation of analyzes of blood samples on whole blood according to the method of the invention.
• This device is characterized in that it comprises:
• At least one zone for preparing said blood samples before analysis comprising means for checking and / or treating said tubes containing said samples, in particular at least one means for agitating said tubes, and at least one access zone for the said samples; less an automatic analyzer on whole blood, said access zone allowing the placement of a said tube in said analyzer, and
• robotic gripping and displacement means controlled by a control automaton and capable of grasping and resting said tubes individually in said storage zone and to convey them in at least three orthogonal directions XYZ between said storage zone, said preparation zone and said access zone to said analyzer, said analyzer preferably being connected and / or controlled by said automaton control.
• said device comprises said supports comprising individual housings in which said tubes are placed by an operator, said supports being positioned in said storage area and manually removable therefrom, said storage area being able to receive a plurality of said supports and being accessible by said robotic gripping and moving means for taking and then replacing the tubes containing the whole blood samples to be analyzed.
• the device of the invention comprises an emergency treatment compartment accessible manually to an operator from outside the device, said emergency treatment compartment being also accessible to said robotic gripping and moving means and having at least one tube support member having at least one housing adapted to receive a tube of blood.
• This emergency treatment compartment allows the introduction or removal of a blood tube at any point in the analysis chain without having to stop the preparation device or the analyzes in progress, which facilitates the preparation and the analysis of blood tubes to be analyzed in priority when they are not in the device.
• said verification and / or treatment means comprise the following options: at least one device for controlling ventilation of said tubes, and / or
• At least one heating means for said tubes preferably consisting of thermoelectric cells.
• the preparation device of the invention comprises a compartment for storing and storing blood tubes. control device for verifying said analyzers, said compartment comprising means for cooling said tubes.
• control blood tubes are positioned and maintained in said storage compartment in individual housings of a said support, said cooling means being constituted by thermoelectric cells (Peltier effect cells) arranged preferably in said housing or on the periphery thereof.
• thermoelectric cells Pelltier effect cells
• control blood storage compartment in the preparation device of the invention advantageously makes it possible to adapt the tube preparation and analysis processes to the national regulations and / or the internal procedures of the laboratories of the invention. analyzes. With this arrangement, all quality control operations, including the verification of analyzers, can be performed automatically and rigorously without the operator having to take care of it to ensure the safety of the results.
• said robotic gripping and moving means comprise an articulated clip adapted to grip said tubes, preferably under the base of the plug, said clip being movable in translation vertically and horizontally along three axes XYZ orthogonal via a translator device having at least three guide rails directed along said XYZ axes and secured in pairs, a first fixed horizontal rail supporting a second horizontal rail perpendicular to said first rail and being movable in translation on it, a last vertical rail being secured to said second rail and movable in translation thereon and perpendicular thereto, said clamp being secured to said third rail.
• these comprise an articulated arm provided at one of its ends with a gripper for gripping said blood tubes, for example of the multi-axis robot type.
• said preparation device is confined in a protective enclosure comprising at least a first access opening to at least one said analyzer and a second access opening to said emergency treatment compartment.
• a protective enclosure also improves operator safety vis-à-vis the risk of projections and / or malfunction of the device.
• the (s) said (s) access area (s) said (s) analyzer (s) comprises (nt) advantageously a mobile carriage adapted to move between said device and a said analyzer, said carriage being controlled by said controller and having at least one housing adapted to receive a said blood tube by said gripping means and displacement .
• said reading means of said tube identification means are integral with said robotic gripping and moving means, and preferably secured to said gripper.
• said robotic gripping and moving means also comprise, in a particular embodiment of the invention, means for detecting and / or displaying said tubes containing said blood samples and said control blood tubes in said storage zones, preparation zone, access zone (s) to said analyzer (s) in said emergency treatment compartment and in said compartment for storing and storing control blood tubes.
• detection and / or visualization means advantageously make it possible to check the presence of a tube in a given location of the tube supports in the storage zone, in the emergency treatment compartment or in the control tube storage compartment. and thus signaling the control program an empty slot for subsequent consideration or simply adjusting the alignment of the gripper with the tube to ensure a good grip and a good displacement of the in the device.
• said supports arranged in said storage area and / or in said storage and storage compartment of the control blood tubes also comprise a identification means adapted to be read by appropriate reading means.
• the preparation device of the invention may also advantageously be coupled to an automatic analyzer in order to constitute a complete automated analysis system integrating all the functions of preparation of the tubes to be analyzed, and quality control of the analyzer, said analyzer comprising a sampling means, in particular a needle, of a blood sample to be analyzed contained in a tube hermetically closed by a stopper presented to it from the preparation device at a said access zone of that -this.
• FIG. 1 shows in perspective and schematically the device for preparing analyzes of whole blood samples according to the invention
• FIG. 2 represents the device of FIG. 1 in plan view
• FIG. 3 represents a partial view of the robotic gripping and moving means of the device of the invention associated with a means of reading the bar code identification of the samples,
• the preparation device 1 for analyzing whole blood samples according to the invention comprises, in the embodiment shown, a working apron 2 on which are delimited and distributed a plurality of treatment areas of blood samples contained in tubes 3 having an identification means 8 of the sample they contain and being sealed by plugs 3a.
• This working apron 2 is covered with a protective and insulating enclosure 4 having recesses 4a, 4b, 4c for access to certain areas of the device as well as an automatic controller 5 of the device.
• Said control automaton is connected to an input keyboard 5a and a touch screen 5b allowing the communication of an operator with the device via a human-machine interface.
• a computer attached to the device and connected thereto may constitute said controller in a manner well known to those skilled in the art.
• the blood tubes 3 are intended to be analyzed in an automatic analyzer after having been prepared for analysis in the device 1.
• Such an automatic analyzer comprises, in known manner, sampling means capable of piercing the plugs 3a of the tubes 3 for take a quantity of blood necessary and sufficient for the tests to be performed or for a blood smear if the analyzer has a blade spreader.
• the analysis preparation device 1 groups together in a single unit all the means adapted to the preparation of the blood tubes 3 before their introduction into the analyzer in order to eliminate all the tedious manual operations practiced to date. by the operators for the preparation and implementation of whole blood tests and thus allow them more time for the biological validation of the results.
• the preparation device of the invention comprises on the working apron 2 a compartment defining a storage area 6 of the blood tubes to be analyzed, wherein said tubes are arranged on supports 7 of multiple capacity comprising a plurality housing, in practice of the order of 25 to 100 dwellings according to the dimensions of said supports.
• Said housings have a format and a depth adapted to receiving and maintaining the blood tubes 3 in a vertical position.
• Such carriers 7 are traditionally used in testing laboratories to rest blood tubes and are known as "racks" of samples.
• the storage compartment 6 has a variable capacity depending on the volume of analysis to be performed daily. In the example shown in the figures, it receives three racks 7 with a capacity of fifty tubes, but for laboratories of small to medium size, it may for example receive from one to two racks 7 or, for laboratories size and more important activity or for hospitals, five or more racks.
• said storage compartment may advantageously be constituted, in a particular embodiment by one or more drawers (not shown) that are pulled to load and unload the racks 7 in the preparation device 1.
• the racks 7 also preferably comprise fasteners or adhesion means on the bottom of the storage compartment, not shown, to hold them in place during the handling operations of the tubes 3 as will be described more after.
• racks 7 it is possible to introduce into the storage compartment 6 racks 7 completely filled with tubes 3 to be analyzed, empty racks, or partially filled racks.
• each tube 3 is prepared by the device 1, then introduced into an automatic analyzer for analysis and replaced after analysis in the storage compartment 6 in the housing of the rack 7 in which it was tidy at the start.
• the device makes it possible, at the request of the operator, to optimize the storage of the tubes in the racks 7 by grouping the tubes 3 at the end of the analysis on a minimum of racks, to save the number of racks used for the conservation of blood tubes and therefore the place in the refrigerators where the tubes are stored after analysis for a day or two.
• said racks are equipped with identification means 8a such as a radiofrequency identification marker, a tape or magnetic tag or a barcode for reading and / or writing information relating to the tubes.
• identification means 8a such as a radiofrequency identification marker, a tape or magnetic tag or a barcode for reading and / or writing information relating to the tubes.
• the tubes 3 and the racks 7 thus identified may be more easily recovered in case of a request for a new analysis.
• This information can be read and recorded advantageously by a suitable reader 9a, such as a radio frequency transponder or a barcode reader, mobile in the storage compartment 6 opposite said identification means and connected to the automaton of order 5.
• the blood tubes 3 also each comprise an identification means 8 of the blood sample it contains.
• This said identification means consists of a bar code or a radiofrequency marker (RFID), for example, and is read via an appropriate reader 9 as soon as the tubes are placed in the compartment of storage. This makes it possible to determine the position of each of the tubes in said storage compartment 6 but also to automatically establish a listing of the tubes present in the device and analyzes they will undergo, which determines the preparation that each of said tubes will have to undergo.
• RFID radiofrequency marker
• radio frequency identification is a particularly well-suited technique for storing and retrieving data on blood samples.
• the markers used may in particular be self-adhesive labels 8, 8a, which may be glued or incorporated into the tubes, and read and automatically updated by the reader 9, 9a at each assumption of load of the tubes.
• the reader 9 means of identification
• the identification means 8 of the tubes and the reader 9a identification means 8a of the rack 7 may be contiguous to each other on the same reading device as shown in Figure 3, thus allowing simultaneous reading of the identification means 8 a tube taken by the clamp 27 and the identification means 8a of the rack 7 in which the tube 3 was taken.
• the device 1 also comprises a preparation zone or preanalytical module 10.
• a preparation zone or preanalytical module 10 In a complementary manner, it also comprises a compartment 11 for storing control blood tubes 19, an emergency treatment compartment 12 communicating with the outside of the device through an opening 4c in the chamber 4 of the device and at least one access zone or compartment 13a, 13b to an automatic analyzer through which the blood tubes to be analyzed or the control blood tubes are made available to the analyzer at two openings 4a, 4b in the chamber 4 after preparation for sampling and analyzes.
• the arrangement of the different zones, modules or compartments of the device on the work apron 2 may be variable.
• the pre-analytical module 10 comprises a plurality of means for preparing and / or processing the blood samples to be analyzed, controlled by said control automaton 5 and by which is automatically conducted a sample preparation sequence determined according to information read on said identification means 8 of the tubes 3 and / or information entered into said controller by the operator responsible for the analysis of said samples.
• the pre-analytical module comprises a stirrer 14, preferably rotating, comprising three stirring wheels comprising an insertion housing for the tube to be agitated and mounted on a common rotation shaft, which makes it possible to simultaneously stir three blood tubes in the example of Figures 1 and 2.
• the wheels of the agitator can be coupled in rotation or not, in order to allow a dissociation of the rotation of each wheel of the stirrer and thus an increase in the rate of the device by allowing the introduction and the gripping of tubes of blood in one wheel without stopping the agitation of the other wheels.
• stirring by partial inversion of the tubes or even a VORTEX-type stirring using means able to rotate the tube on itself, these modes and stirring means being well known. those skilled in the art in the field of blood tests.
• the number of stirring chambers can be chosen, such as the capacity of the storage compartment, depending on the rate of analysis to be performed.
• the pre-analytical module also comprises a device 15 for aeration of said tubes, comprising a piercing needle of the plug of the tube making it possible to neutralize a depression or a residual pressure in the tube so that the analyzer can correctly collect the blood in the tube. tube.
• the pre-analytical module also comprises a device 17 for checking the level of depression of the plug of the tubes and, where appropriate, a device 18 for heating said tubes 3 to carry certain samples at an ideal analysis temperature in the case of certain pathologies of blood or when said blood samples leave the refrigerator.
• these heating means preferably consist of cells thermoelectric, for example Peltier cells, which can thus, depending on the polarity of the current with which they are fed, either heat or cool said samples.
• the preparation device 1 also comprises, in accordance with another advantageous characteristic thereof, a compartment 11 for storing and preserving control blood tubes 19, that is to say, tubes of blood that are useful daily to the patient. verification of automatic whole blood analyzers, said compartment comprising means for cooling said tubes.
• this compartment 11 which, contrary to the figures shown for the sake of clarity, is preferably insulated, said control blood tubes 19 are positioned and held in the individual housings of a metal support 20 equipped with cells. thermoelectric (Peltier effect cells) in said housing or on the periphery thereof in order to keep the control blood tubes 19 cold and thus guarantee their good preservation over time.
• the preparation device finally comprises an emergency treatment area or compartment 12 accessible by an operator from outside the device through an opening 4c in the chamber of the device 1 without having to stop the preparation and the analysis.
• This emergency treatment compartment 12 is intended for the management of all emergency analysis situations or unconventional analyzes that usually disrupt the proper operation of the analyzers. This is for example the case for tubes equipped with a plug not pierceable by the needle of the analyzer, which are outlets before provision of the analyzer, or for smaller format tubes, usually used to collect blood on children, and that require an adapter to be then introduced into the automatic analyzer.
• a rack 21 of small capacity comprising a maximum of about ten housings 22, is placed in said emergency treatment compartment 12 to receive one or more tubes 23 placed directly by the operator manually in said housings 22 of the rack 21 for that the preparation device supports them individually and primarily on the blood tubes 3 stored in the storage compartment 6.
• the housings 22 can also be used to make available to the operator a blood tube 3 previously placed in the storage compartment 6 without interrupting the automatic analysis chain. The operator can very easily and safely retrieve a specific tube for example, to perform additional analysis.
• said device advantageously comprises robotic gripping and displacement means 24, 25, 26, 27 controlled by said control automaton 5.
• a translating device comprising at least three motorized guide rails 24 , 25, 26 along three orthogonal axes XYZ and solidary two by two, a first rail 24, horizontal and fixed, extending from one side of the deck 2 in its largest dimension and supporting a second rail 25, also horizontal and perpendicular to said first rail 24.
• This second rail 25 is movable in translation on said first rail according to the double arrow Fl, and a last vertical rail 26 is integral with said second rail 25 and movable in horizontal translation along the double arrow F2 thereon and in vertical translation along the double arrow F3 perpendicular to it, said clamp 27 being secured to the third rail 26
• said clamp 27 is rotatably mounted on said third rail 26 so as to be pivotable about a vertical axis parallel to the Z axis.
• the clamp 27 allows to capture a tube 3 and to rotate it on itself, which is particularly interesting to perform an individual reading of the identification means 8 (a barcode in the figures) of each tube placed in the racks 7, 21 of the storage compartment 6 or the emergency treatment compartment 12 using a reader 9 associated with said rotary clamp 27 as shown in FIG. 3.
• the rotation of the tube makes it possible to quickly find an area of the identification means not hidden by the jaws of the clamp 27 to perform the reading and recording of the data read in the control controller without having to move the tube along the translator rails to a fixed reader at a determined position in the device. This saves a significant amount of time in the priming phase of the preparation of the blood samples to be analyzed.
• the preparation device 1 of the invention being associated for example with an automatic analyzer 28 identified by a side wall in FIG. 1, said analyzer 28 being connected and able to communicate via a network module not shown at the control automaton 5 of the preparation device 1.
• a start-up phase of the analyzer 28 and the preparation device 1 which takes place in the morning before the start of the analyzes and during which mechanical and electronic controls of the instrument, as well as rinses and ignitions liquids and analysis reagents are made, it triggers from the controller 5 a verification phase, also called “quality control” phase which is mandatory and is managed fully automatically and autonomously by the device of preparation.
• control blood tubes 19 are stored in the storage compartment 11 of the preparation device 1.
• This has the advantage that the choice of control blood tubes as well as the control and Validation, which can be parameterized by the user to adapt to the legislation in force in each country or according to the laboratory, are managed by the preparation device.
• the automation of the tasks makes it possible to strictly observe the conditions of use of the control bloods. These conditions mainly concern the expiry date, the storage conditions, the maximum number of samples that can be taken in a tube already used and the conditions of reheating and agitation.
• the robotic gripper 27 selects the control blood tube 19 to be analyzed in the storage compartment 11 of the preparation device and deposits it in the heating device 18 in order to accelerate the reheating and then to reduce the temperature.
• agitator 14 to homogenize the blood contained in the tube. If necessary, it will be possible to use heating stirrers to benefit from the stirring phenomenon to accelerate the heating of the control blood tubes.
• control blood tube 19 is then deposited by the robotic gripper 27 in the carriage 29b in the access zone 13b in order to be introduced into the analyzer 28 and analyzed.
• the control blood tube 19 once analyzed is then transported from the analyzer 28 to the preparation device 1 via the carriage 29b, and then to its original location in the storage compartment 11 by the robotic gripper 27.
• the identification means 8 of the test tube are read.
• control blood 19 when it is taken over by the robotic gripper 27 to detect any accidental reversal of the control tubes 19 in the storage compartment 11.
• the results are then displayed on the control panel 5b of the controller 5 and stored and stored therein. This makes it possible to automatically check the results of a control and if these results go beyond the limits of tolerance, to carry out a new analysis of the same tube of control blood or of a new tube available in the refrigerated storage compartment and this until 'to obtain correct results.
• the whole blood tubes 3 are arranged in racks 7 installed by the operator directly in the storage compartment 6 of the preparation device. Once the racks 7 have been loaded into the device 1, the operator starts the process of analyzing the samples from the control automaton 5. In a first step, the clamp 27 will come to take a blood tube 3 to be analyzed in a rack 7 in the storage compartment 6, out of its housing and then read the barcode or radiofrequency marker that serves as identification means 8 to transmit to the controller 5 the position of the tube in the rack 7 .
• the clamp 27 then moves the tube 3 from the storage compartment 6 to the pre-analytical module 10 to begin the preparation of the sample.
• the robotic gripper 27 first brings the tube 3 to the aeration device 15 of the tube, then the robotic gripper then brings the tube to the optical detector 16 to check the level of blood in the tube and the possible presence of clots. If this verification is validated, the tube 3 is then transported by the robotic gripper 27 to the station 17 for checking the level of depression of the plug of the tube. If it is correct, the clamp then comes to place the tube in the agitator 14 so that it undergoes a Sustained agitation phase, as recommended by NCCLS (Standards and Regulations promoted by The Cllnical and Laboratory Standards Institute).
• the forceps 27 extracts the blood tube to be analyzed from the agitator 14 and transports it to an access zone 13a, 13b to the analyzer where it depositing the tube 3 in a translating carriage 29a, 29b equipped with a support adapted to maintain the tube in a position appropriate to its entry into the analyzer and the collection therein of an amount of blood sufficient for analysis.
• a translating carriage 29a, 29b equipped with a support adapted to maintain the tube in a position appropriate to its entry into the analyzer and the collection therein of an amount of blood sufficient for analysis.
• the carriage When the collection of blood in the tube is carried out by the analyzer, the carriage then returns to its starting position in the access compartment of the preparation device where the robotic gripper 27 again grips the tube and transport it to at its starting location in a rack 7 in the storage compartment.
• the robotic clamp 27 it is also possible to program the robotic clamp 27 so that the whole blood tubes are not returned to their original place after analysis but placed in another rack 7, empty, in the compartment storage 6 of the preparation device, or sorted according to the result of the analysis performed in different empty racks provided for this purpose in the storage compartment.
• the tube sorting function is particularly advantageous in that it makes it possible to group all the tubes requiring additional examination in a single rack 7 to prevent the operator from performing himself a manual sorting operation.
• the sample preparation operations are preferably carried out simultaneously on several tubes as shown in FIG. 1.
• the control automaton 5 manages the various movements of the tubes by the robotic gripper 27 so as to optimize the duration of the stirring and the waiting time which must be minimum between the end of the stirring and the analysis.
• the transport trolleys of the tubes to the analyzer comprise a plurality of housings for receive several blood tubes to be analyzed before entering the analyzer, so as to slightly anticipate the loading of the tube to be analyzed and allow time for the PLC to recover the tube returned by the analyzer.
• the rack can thus contain the tube to be analyzed and one or more tubes already analyzed. This arrangement optimizes the movements of the clamp and keep a high rate.
• the preparation device of the invention also makes it possible to manage the cases in which an operator must carry out emergency analyzes on blood tubes 3 present in the storage compartment 6 of the device 1 or on tubes 23 coming from outside. it was not planned to analyze. This situation is very common but difficult to manage in a highly automated laboratory where it is necessary to interrupt the analyzes in progress to pass the tube or tubes considered emergency.
• the operator can place it in the rack 21 in the emergency treatment compartment 12 and program via the keyboard 5a or the touch screen 5b of the control unit 5, the support of this tube by the robotic gripper 27 in priority on the tubes located in the storage compartment 6 in order to perform the emergency analysis of this tube without breaking the automatism of the analysis chain.
• the emergency treatment compartment 12 gives the operator privileged access to perform all the exceptional and non-automatable operations, as well as to retrieve a tube 3 present inside the device, which the robotic clamp can easily pick up. come to make available in the rack 21 in the emergency treatment compartment 12.
• the preparation device 1 of the invention also allows a great modularity of installation in the analysis laboratories in combination with the various categories of automatic analyzers traditionally used in these laboratories. As shown in FIG. 4, it is thus possible to couple to the device of the invention 1 two analyzers 28, 30.
• the analyzer 28 is preferably a cell counter and the analyzer 30 is preferentially an automaton for making blood smears and specifically stain the spread cells to facilitate subsequent observation under the microscope.
• the device 1 interposed between the analyzers 28 and 30, positions the tube 3 to be analyzed in the carriage 29b of the access zone 13b of the analyzer 28 and the tube 3 requiring a blood smear in the carriage 29a of the access zone 13a of the automaton 30.

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• Analytical Chemistry (AREA)
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• 2005
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• 2006
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